Guided Heart Mapping Device Used in Catheter Ablation for Irregular Heartbeat
Studies a guidance device during catheter ablation in adults with atrial flutter or atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Key facts
- Where
- Prague, CzechiaSee the 2 sites
Where in Czechia
- IKEMPrague, CzechiaNot yet recruiting
- Na Homolce HospitalPrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LUMA Vision Ltd.
- Trial code
- NCT07210151
- Record updated
- 3 November 2026
- Original description
The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).Read full original descriptionShow less
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).
The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.
Inclusion: IC1: Subject is at least 18 years of age at the time of consent; IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (*according to current international and local guidelines and per physician discretion); IC3: Subject is able to understand and willing to provide written informed consent; IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site.
Exclusion: EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure); EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure; EC6: Current LA thrombus; Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present; EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion; EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure; EC5: Life expectancy less than 12 months.